IPlex
Generic name: mecasermin rinfabate [rDNA origin]
Treatment for: Primary IGF-1 Deficiency
FDA Extends PDUFA Date for SomatoKine to October 3, 2005
RICHMOND, Va., June 10, 2005 - Insmed Incorporated (NASDAQ: INSM) today announced that it has received notification from the United States Food and Drug Administration (FDA) that the agency expects to complete the priority review of SomatoKine on or before October 03, 2005, which is a three month extension from the original user fee goal date.
The extension is a result of the agency classifying responses to questions about the NDA as a major amendment to the NDA. The agency has reset the user fee goal date to give it additional time to review the information contained in the Company's response.
"We welcomed the opportunity to address questions the FDA had regarding our NDA," said Geoffrey Allen, President and CEO of Insmed. "The Company has not been notified of any specific deficiencies and we believe we have thoroughly and comprehensively addressed all of their questions. We remain confident that SomatoKine will become an important therapy for the treatment of growth hormone insensitivity syndrome (GHIS).
About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs.
For more information, please visit the Insmed website.
Posted: June 2005
Related articles
- iPlex Insmed Incorporated - Treatment for Severe Primary IGF-1 Deficiency - December 12, 2005
- FDA to Review Insmed's Complete Response to Approvable Letter for iPlex - October 25, 2005
- Insmed Submits Response to FDA Approvable Letter for iPlex - October 17, 2005
- Insmed Receives Approvable Letter for iPlex - September 27, 2005
- FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - March 10, 2005
- Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - January 3, 2005
IPlex (mecasermin rinfabate [rDNA origin]) FDA Approval History
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